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Prior to beginning research in the Clinical Research Center (CRC) (G-5035), researchers are required to submit an application for approval by the CRC. Instructions are detailed below. It is most helpful to address issues of concern prior to protocol submission. Questions about the application process or use of CRC services should be addressed to the following CRC personnel:

Application Process: Venita Byrd at (585) 275-0654

Nursing and DXA: Ann Miller at (585) 275-2907

Nutrition Research: Nellie Wixom at (585) 275-3918 

Protocol Approval Process

The CRC must approve a protocol prior to conducting research procedures on study subjects on the CRC or using CRC resources. 

Please note the following information about the CRC protocol submission/review process:

  • IRB (RSRB, single IRB, or central IRB) approval is required prior to CRC review.
  • CRC review consists of a feasibility review for the requested use of CRC services or resources. The CRC is committed to prompt review of the protocol for feasibility.
    • The review process starts upon receipt of the CRC application, IRB approval, and all required study documents.
    • If there are no questions or issues needing clarification during the review process, the protocol can be approved and a CRC protocol number can be provided by the fifth business day after CRC receipt of the protocol.
    • If the PI responds promptly to any questions or items of clarification arising from the review, it is estimated that the turnaround time for the feasibility review would be a total of two weeks from CRC receipt of the complete protocol submission package.
    • The CRC strongly encourages study teams to work with the CRC staff prior to protocol submission to work out potential issues and reduce time to approval.

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Application Process

New Protocol Submissions

  • Protocols reviewed by the RSRB:
    1. When filling out the protocol application in the Click IRB system, indicate that the study will use the resources of the CRC. This will provide the CRC with access to the study documents, IRB approval documents, and future amendments.
    2. After RSRB approval has been received, submit the CRC Protocol Submission Application electronically to UR CTSI. If you did not indicate at initial RSRB submission that the study will use the resources of the CRC, attach the required study documents detailed in the table below, as well as the departmental scientific review of the study.
  • Protocols reviewed by an IRB external to the University of Rochester – Submit the following documents electronically to UR CTSI:
    • CRC Protocol Submission Application
    • IRB approval
    • IRB-approved consent form(s)
    • Departmental scientific review of the study
    • Required study documents detailed in the table below

Once the required documents are received, the CRC feasibility review will begin.

The table below details the components required for CRC protocol review. The required components are based upon the involvement of the CRC in the study. Incomplete submissions may result in delay of review.

CRC Involvement

Protocol

IRB-Approved Consent Form

IRB Documentation of Approval

Manual or the Portion thereof that Relates to the Tests Conducted on the CRC

Measures/ Assessments to be Conducted in the CRC

Nursing

yes

yes

yes

yes

yes

Nutrition Services

yes

yes

yes

no

no

Blood draw and processing (blood drawn on the CRC)

yes

yes

yes

yes

no

Blood processing (blood draws not conducted on the CRC)

yes

yes

yes

yes

no

Vital signs only

yes

yes

yes

no

no

DXA

yes

yes

yes

no

no

CRC Use (no services required)

yes

yes

yes

no

no

Adding Use of CRC Resources or Services to a Study that has Already Received IRB Approval

Submit the following documents electronically to UR CTSI:

  • CRC Protocol Submission Application
  • IRB approval
  • IRB-approved consent form(s)
  • Departmental scientific review of the study
  • Required study documents detailed in the table above

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Protocol Amendments

  • When a protocol amendment impacts the CRC, a CRC Amendment Submission Form and supporting documentation need to be submitted to UR CTSI for CRC review. It is the responsibility of the study team to communicate protocol changes that impact the CRC.

Regardless of whether or not an amendment directly impacts the CRC, if the protocol or consent form is revised, a revised copy of the protocol or consent form needs to be forwarded to UR CTSI.

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Fees

  • Fees for use of the Clinical Research Center are substantially subsidized, up to 80% of costs. View the current fee schedule.
  • The Clinical Research Center provides cost estimates to assist in budget development for grants or industry-funded protocols. To request a cost estimate, please submit a CRC Cost Estimate Request Form to UR CTSI, along with the protocol or portion of the grant detailing the research study.

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Forms

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